DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
1. Claims 1-2 and 19-26 are pending and under examination on the merits.
Claims 6-16 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made with traverse in the reply filed on March 14, 2025.
Claims 3-5 and 17-18 are cancelled.
Response to Arguments – Claim Objections
2. Applicant’s arguments and amendments filed 07/21/2026 have overcome the objections of record.
Response to Arguments – Claim Rejections - 35 USC § 112(b)
3. Regarding the rejection of claims 1-2 under 35 U.S.C. 112(b), Applicant’s arguments and amendments filed 07/21/2026 have overcome the rejections of record. However, said amendments have necessitated new grounds of rejection under 35 U.S.C. 112(b).
Claim Rejections - 35 USC § 112(b)
4. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
5. Claims 1-2 and 19-26 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is indefinite because the structure, and therefore, scope of the claimed mutant CPT family protein is unclear for the reasons discussed below. For the reasons discussed below, the recitations in lns. 3-29 are confusing and unclear and do not appear to add further structure to SEQ ID NO:12. In particular, lns. 3-4, 8-12, 17-21, and 27-29 appear to describe traits, features, and/or regions of a wildtype protein. For the purpose of compact prosecution, claim 1 is interpreted to encompass a mutant CPT family protein comprising an amino acid sequence having at least 95% sequence identity to SEQ ID NO:7, wherein the protein comprises positions 1-32 of SEQ ID NO:1, and wherein the mutant CPT protein binds to NgBR. If none of the clauses recited in lns. 3-29 add further structure to the claimed mutant CPT family protein, it is suggested Applicant delete the recitations in lns. 3-29.
The metes and bounds of claim 1 are indefinite because it is unclear what is encompassed by a region that “corresponds” to positions in another protein. Does the N-terminal regional that corresponds to position 1-72 of SEQ ID NO:3 comprise positions 1-72 of SEQ ID NO:3? Is the N-terminal regional that corresponds to position 1-72 of SEQ ID NO:3 limited to a region consisting of 72 amino acids? It is unclear how an N-terminal region corresponding to positions 1-34 of SEQ ID NO:4 can comprise 95% sequence identity to positions 1-72 of SEQ ID NO:1. Sequences within 95% sequence identity positions 1-72 of SEQ ID NO:1 encompass those comprising insertions, deletions, and/or substitutions of up to four amino acids; thus, the broadest reasonable interpretation of an N-terminal region having 95% sequence identity to positions 1-72 of SEQ ID NO:1 is limited to a region having only 68-76 amino acids. If an N-terminal region corresponding to positions 1-34 of SEQ ID NO:4 comprises only 34 amino acids, it is unclear how such a reason could have 95% sequence identity to a region comprising 72 amino acids. It is unclear how a C-terminal region corresponding to positions 278-302 of SEQ ID NO:3 or to positions 342-368 of SEQ ID NO:4 can comprise 95% sequence identity to positions 279-368 of SEQ ID NO:1. Sequences within 95% sequence identity positions 279-368 of SEQ ID NO:1 encompass those comprising insertions, deletions, and/or substitutions of up to four amino acids; thus, the broadest reasonable interpretation of a C-terminal region having 95% sequence identity to positions 279-368 of SEQ ID NO:1 is limited to a region having only 85-93 amino acids. If a C-terminal region corresponding to positions 278-302 of SEQ ID NO:3 or to positions 342-368 of SEQ ID NO:4 comprise only 24 and 26 amino acids, respectively, it is unclear how such a reason could have 95% sequence identity to a region comprising at least 82 amino acids. The structure of a protein that corresponds to positions on another protein is open to multiple reasonable interpretations and is therefore indefinite.
Claims 20-21 are also indefinite because the recitation of an N-terminal region and C-terminal region “corresponding” to a region on another protein are indefinite for the reasons described above.
The scope of claim 26 is indefinite because it is unclear what is encompassed by a HRT1-REF binding protein (HRBP) “derived” from a rubber tree. It is unclear what features/structures are retained in the derived HRBP in comparison to the protein from which it is derived. It is unclear if the derived HRBP was discovered in/obtained from, and therefore natively present in, the recited species/organisms. Therefore, the structure of the recited NgBR and its relation to the HRBP from which it was “derived” is unclear.
Dependent claims are included. Appropriate correction is required.
Response to Arguments – Claim Rejections - 35 USC § 112(a)
6. Applicant’s arguments and amendments filed 07/21/2026 have overcome the rejections of record.
Response to Arguments – Double Patenting
7. Applicant’s arguments and amendments filed 07/21/2026 have been fully considered but are not persuasive and do not overcome the rejections of record.
Applicant traverses the rejections and requests reconsideration of the claims in view of the present amendments. Applicant does not provide a clear argument explaining if and/or how the previously and/or currently presented claims are patentably distinct from the copending claims.
Furthermore, claim 1 is indefinite (see rejection of claims under 35 U.S.C. 112(b)) and is herein interpreted to encompass a mutant CPT family protein comprising an amino acid sequence having at least 95% sequence identity to instant SEQ ID NO:12, wherein the protein comprises positions 1-32 of SEQ ID NO:1, and wherein the mutant CPT protein binds to NgBR. Claim 1 of copending Application No. 18/164,700 is indefinite because the structure, and therefore, scope of the claimed mutant CPT family protein is unclear. Copending claim 1 is herein interpreted to encompass a mutant CPT family protein comprising an amino acid sequence having at least 95% sequence identity to copending SEQ ID NO:7, wherein the protein comprises positions 1-32 of copending SEQ ID NO:1, and wherein the mutant CPT protein binds to NgBR. Instant SEQ ID NO:1 and copending SEQ ID NO:1 are identical sequences. Instant SEQ ID NO:12 and copending SEQ ID NO:7 are identical sequences (see below). Thus, instant claim 1 and copending claim 1 are directed to the same polypeptide sequence, and therefore, the same invention.
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Accordingly, the claims remain rejected on the grounds of nonstatutory double patenting as being unpatentable over claims of copending Application No. 18/164,700 in view of Liang et al. (European Journal of Biochemistry. 2002; 269(14):3339-3354 (previously cited)). Furthermore, Applicant’s amendments have necessitated new grounds for rejections.
Non-Statutory Double Patenting
8. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
9. Claims 1-2, 19, and 21-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 17-19, and 21-23 of copending Application No. 18/164,700 in view of Liang et al. (European Journal of Biochemistry. 2002; 269(14):3339-3354 (previously cited)). Although the claims at issue are not identical, they are not patentably distinct from each other.
Instant claim 1 is indefinite (see rejection of claims under 35 U.S.C. 112(b)). For the purpose of compact prosecution, instant claim 1 is herein interpreted to encompass a mutant CPT family protein comprising an amino acid sequence having at least 95% sequence identity to SEQ ID NO:12, wherein the protein comprises positions 1-32 of SEQ ID NO:1, and wherein the mutant CPT protein binds to NgBR. Claim 1 of copending Application No. 18/164,700 is indefinite because the structure, and therefore, scope of the claimed mutant CPT family protein is unclear. The recitations in lns. 3-14 and 16-17 of copending claim 1 are confusing, unclear, and do not appear to add further structure to copending SEQ ID NO:7. Accordingly, copending claim 1 is interpreted to encompass a mutant CPT family protein comprising an amino acid sequence having at least 95% sequence identity to copending SEQ ID NO:7, wherein the protein comprises positions 1-32 of SEQ ID NO:1, and wherein the mutant CPT protein binds to NgBR. Instant SEQ ID NO:1 and copending SEQ ID NO:1 are identical sequences. Instant SEQ ID NO:12 and copending SEQ ID NO:7 are identical sequences. Therefore, instant claim 1 and copending claim 1 are directed to the same polypeptide sequences, and therefore, the same invention.
Claim 1 of Application co-pending No. 18/164,700 is silent to but does not exclude mutations within a C-terminal region of the CPT family protein.
Liang teaches a mutant CPT family protein obtained by mutating an amino acid sequence of an N-terminal region and C-terminal region of said protein (p. 3343, right column, first full paragraph).
One of ordinary skill in the art would be motivated to produce a CPT family protein comprising mutations in both the N- and C-terminus of the protein and it would have been prima facie obvious to do so, because Liang teaches that mutations of N-terminal and C-terminal amino acids within the hydrophobic tunnel of the E. coli UPPS results in the generation of 60-, 65-, and 70-carbon chain-length products in comparison to the 55-carbon product generated by the wildtype enzyme (Liang, p. 3344, “Mechanism of product chain-length determination in cis-IPPS”). Accordingly, one of ordinary skill in the art would have been motivated to produce the claimed invention with a reasonable expectation of success and without any surprising results. Because claim 1 of co-pending Application No. 18/164,700 also encompasses CPT family proteins further comprising mutations within a C-terminal region, instant claim 1 is unpatentable over claim 1 of co-pending Application No. 18/164,700 in view of Liang.
Regarding instant claim 2, claim 2 of co-pending Application No. 18/164,700 further recites a mutation wherein the N-terminal region of the mutant CPT family protein shares at least 98% sequence identity with a wildtype CPT protein. Instant claim 2 requires the claimed protein share at least 98% sequence identity to a wildtype protein in both its N-terminal and C-terminal regions. Because claim 2 of co-pending Application No. 18/164,700 encompasses CPT family proteins further comprising mutations within a C-terminal region, instant claim 2 and claim 2 of co-pending Application No. 18/164,700 are not patentably distinct in view of Liang.
Regarding instant claim 19, claim 17 of co-pending Application No. 18/164,700 further recites a mutation wherein the N-terminal region of the CPT family protein shares at least 99% sequence identity with a wildtype CPT protein. Instant claim 19 requires the claimed protein share at least 99% sequence identity to a wildtype protein in both its N-terminal and C-terminal regions. Because claim 17 of co-pending Application No. 18/164,700 encompasses CPT family proteins further comprising mutations within a C-terminal region, instant claim 19 and claim 17 of co-pending Application No. 18/164,700 are not patentably distinct.
Both instant claim 20 and copending claim 18 recite identical additional limitations wherein the N-terminal region of the mutant CPT family protein is within 35 amino acids downstream of the N-terminus. Accordingly, instant claim 20 and copending claim 18 are not patentably distinct.
Regarding instant claim 21, the claim is indefinite for the reasons described above in the rejection of the claims under 35 U.S.C. 112(b). Similarly, claim 18 of copending Application No. 18/164,700 also recites an indefinite N-terminal amino acid sequence that is downstream of the N-terminus of the mutant CPT family protein. Accordingly, instant claim 20 and claim 18 of copending Application No. 18/164,700 are not patentably distinct. Though claim 18 of Application co-pending No. 18/164,700 is silent to mutations within a C-terminal region of the CPT family protein, such mutations are not excluded from the claim. Furthermore, mutations within a C-terminal region of a CPT family protein are rendered obvious in view of the teachings of Liang, as discussed above (p. 3343, right column, first full paragraph).
Instant claim 22 and copending claim 19 recite additional limitations wherein the mutant CPT family protein comprises the amino acid sequence of instant SEQ ID NO:12 and copending SEQ ID NO:7, respectively. Because instant SEQ ID NO:12 is identical to copending SEQ ID NO:7 and instant claim 1 is deemed patentably indistinct from copending claim 1, instant claim 22 and copending claim 19 are not patentably distinct.
Instant claim 24 and copending claim 21 recite additional limitations wherein the mutant CPT family protein comprises an amino acid sequence having at least 98% sequence identity to instant SEQ ID NO:12 or copending SEQ ID NO:7, respectively. Because instant SEQ ID NO:12 is identical to copending SEQ ID NO:7 and instant claim 1 is deemed patentably indistinct from copending claim 1, instant claim 24 and copending claim 21 are not patentably distinct.
Instant claim 25 and copending claim 22 recite additional limitations wherein the mutant CPT family protein comprises an amino acid sequence having at least 99% sequence identity to instant SEQ ID NO:12 or copending SEQ ID NO:7, respectively. Because instant SEQ ID NO:12 is identical to copending SEQ ID NO:7 and instant claim 1 is deemed patentably indistinct from copending claim 1, instant claim 25 and copending claim 22 are not patentably distinct.
Instant claim 26 and copending claim 23 recite identical limitations wherein the NgBR is an NgBR family protein corresponding to HRT1-REF bridging protein (HRBP) derived from a rubber tree. Because instant SEQ ID NO:12 is identical to copending SEQ ID NO:7 and instant claim 1 is deemed patentably indistinct from copending claim 1, instant claim 26 and copending claim 23 are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Statutory Double Patenting
10. A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
11. Claim 23 is provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 20 of copending Application No. 18/164,700. Instant claim 23 is directed to a mutant CPT family protein consisting of instant SEQ ID NO:12. The term “consisting of” excludes additional factors; therefore, the amino acid sequence of the mutant CPT family protein of instant claim 23 is SEQ ID NO:12. Copending claim 20 is directed to a mutant CPT family protein consisting of copending SEQ ID NO:7; therefore, the amino acid sequence of the mutant CPT family protein of copending claim 20 is copending SEQ ID NO:7. Instant SEQ ID NO:12 is identical to copending SEQ ID NO:7. Thus, instant claim 23 and copending claim 20 are directed to the exact same sequence, and therefore, the same invention.
This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Conclusion
12. No claim is allowed. The closest prior art, Alexandrov et al. (EP1033405-A2, published 09/06/2000 (N)), teaches a CPT family protein (SEQ ID NO:49062) wherein the CPT family protein has at least 87.5% sequence identity to the amino acid sequence of SEQ ID NO:12. However, Alexandrov does not teach NgBR or an CPT family protein having at least 95% sequence identity to SEQ ID NO:12.
13. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Examiner’s Contact Information
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEQUANTARIUS J SPEED whose telephone number is (703)756-4779. The examiner can normally be reached M-F; 9AM-5PM ET.
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/DEQUANTARIUS JAVON SPEED/Junior Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663
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